Phase 2 clinical trial of hypothalamic damage obesity drug initiated
LG Chem’s new drug for rare obesity, developed and exported through technology, is entering full-scale development.
LG Chem announced on the 24th that its partner company Rhythm Pharmaceuticals has started administering the drug to the first subject in the phase 2 clinical trial of ‘LB54640’.
In this phase 2 clinical trial, Rhythm Pharmaceuticals plans to recruit 28 patients with hypothalamic obesity aged 12 years or older who have impaired hypothalamic function and have difficulty controlling appetite and evaluate the change in body mass index (BMI) after 14 weeks of taking LB54640. In the extension study, the safety after long-term use for 52 weeks will be analyzed.
LB54640 is a satiety signal gene (MC4R) agonist that LG Chem developed in-house and exported its technology to Rhythm Pharmaceuticals in January. It received $100 million (approximately KRW 130 billion) in advance payment, the largest amount of technology export in the domestic pharmaceutical industry in the first half of this year. The technology fee (milestone) according to the development and commercialization stage is up to $205 million (approximately KRW 270 billion).
At the investor briefing held in May, Rhythm Pharmaceuticals listed the acceleration of LB54640 development as one of the three major tasks for increasing the company’s value, and expressed its will to actively invest. The strategy is to focus on expanding the indications of Rhythm Pharmaceuticals’ daily injection-type obesity treatment ‘Imsibri’ as a commercial product, while also accelerating the development of MC4R agonist ‘LB54640’ with improved administration convenience.
David Meeker, CEO of Rhythm Pharmaceuticals, said, “Based on the preclinical and phase 1 clinical data from LB54640, we have confirmed the potential to develop an effective MC4R agonist without side effects such as skin pigmentation. We will provide a broad portfolio to patients around the world suffering from severe obesity so that they can choose the treatment option that is right for them.”
Source: kormedi.com